Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00503724
Status:
COMPLETED
Last Update Posted:
2012-03-06
First Post:
2007-07-17
Brief Title:
Enzastaurin in Treating Young Patients With Refractory Primary CNS Tumors
Sponsor:
Pediatric Brain Tumor Consortium
Organization:
Pediatric Brain Tumor Consortium
Study Overview
Official Title:
Phase I and Pharmacokinetic Study of Enzastaurin LY317615 in Children and Adolescents With Refractory Primary CNS Tumors
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Enzastaurin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor
PURPOSE This phase I trial is studying the side effects and best dose of enzastaurin in treating young patients with refractory primary brain tumors
PURPOSE This phase I trial is studying the side effects and best dose of enzastaurin in treating young patients with refractory primary brain tumors
Detailed Description:
OBJECTIVES
Primary
To estimate the maximum tolerated dose MTD andor recommend a phase II dose of enzastaurin hydrochloride in children with recurrent or refractory CNS tumors who are not receiving enzyme-inducing anticonvulsants
To further characterize the pharmacokinetics and toxicity of the recommended phase II dose of enzastaurin hydrochloride given twice daily in these patients
Secondary
To characterize the pharmacokinetics of enzastaurin hydrochloride at the recommended phase II dose given once a day or twice a day in children
To document and describe toxicities associated with enzastaurin hydrochloride
To document antitumor activity in children with recurrent or refractory CNS tumors
To explore changes in MR perfusion scans obtained within 15 2 days after initiation of enzastaurin hydrochloride therapy as compared to baseline and to correlate these changes with clinical outcome
To evaluate a panel of biological surrogate markers in this patient population at baseline and following enzastaurin hydrochloride administration
OUTLINE This is a multicenter study
Patients receive oral enzastaurin hydrochloride once daily until the maximum tolerated dose MTD is determined Patients then receive enzastaurin hydrochloride at the MTD twice daily on days 1-28 Treatment repeats every 28 days for 13 courses in the absence of disease progression or unacceptable toxicity Patients may receive 13 additional courses for a total of 26 courses of oral enzastaurin hydrochloride if the patient is benefitting from the treatment and the investigator and subject agree to continue treatment
Patients undergo blood sample collection periodically for pharmacokinetic studies
After completion of study treatment patients are followed periodically
Primary
To estimate the maximum tolerated dose MTD andor recommend a phase II dose of enzastaurin hydrochloride in children with recurrent or refractory CNS tumors who are not receiving enzyme-inducing anticonvulsants
To further characterize the pharmacokinetics and toxicity of the recommended phase II dose of enzastaurin hydrochloride given twice daily in these patients
Secondary
To characterize the pharmacokinetics of enzastaurin hydrochloride at the recommended phase II dose given once a day or twice a day in children
To document and describe toxicities associated with enzastaurin hydrochloride
To document antitumor activity in children with recurrent or refractory CNS tumors
To explore changes in MR perfusion scans obtained within 15 2 days after initiation of enzastaurin hydrochloride therapy as compared to baseline and to correlate these changes with clinical outcome
To evaluate a panel of biological surrogate markers in this patient population at baseline and following enzastaurin hydrochloride administration
OUTLINE This is a multicenter study
Patients receive oral enzastaurin hydrochloride once daily until the maximum tolerated dose MTD is determined Patients then receive enzastaurin hydrochloride at the MTD twice daily on days 1-28 Treatment repeats every 28 days for 13 courses in the absence of disease progression or unacceptable toxicity Patients may receive 13 additional courses for a total of 26 courses of oral enzastaurin hydrochloride if the patient is benefitting from the treatment and the investigator and subject agree to continue treatment
Patients undergo blood sample collection periodically for pharmacokinetic studies
After completion of study treatment patients are followed periodically
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PBTC-023 | OTHER | Pediatric Brain Tumor Consortium | httpsreporternihgovquickSearchU01CA081457 |
| U01CA081457 | NIH | None | None |